Immunogenicity and Safety Analysis of Inactivated Virus Vaccine against SARS-CoV-2: A Systematic Review of Phase 1/2 Clinical Trials

Abstract

Introduction: The lingering Severe Acute Respiratory System-Coronavirus-2 (SARS-CoV-2) pandemic worldwide has called scientists to accelerate vaccine production and reduce the spread of the virus. The inactivated virus vaccine has been administered widely due to its potency. Following its recent public use, we aim to summarize the efficacy and safety of the inactivated vaccine, especially following Indonesia’s settlement on the SinoVac vaccine.
 Materials and Methods: A systematic review was performed, searching for randomized controlled trials, according to the PRISMA statement throughout four online databases with studies published up to 2 February 2021. Critical appraisal was further conducted utilizing the Cochrane Risk of Bias Tool 2.0.
 Results and Discussions: The search yielded six phase ½ clinical trials with a total of 3251 subjects. The outcome was obtained in seroconversion rates (%) after two doses of vaccine. Four studies administered the CoronaVac inactivated vaccine and resulted in a high seroconversion rate, ranging from 89—90%. The other two studies administered the BBV152 and BBIBP-CorV inactivated vaccine and showed similar results. Furthermore, a dose dependent relation is shown with higher doses showing higher seroconversion rates. The safety analysis reported injection site pain as an insignificant but most prevalent local adverse reaction, with other adverse reactions being mild to moderate respiratory tract infections
 Conclusion: The inactivated vaccine’s efficacy has been proven to stimulate antibody response regardless of dosage, period of administration, and age, with insignificant adverse effects. Further phase 3 clinical trials and widespread administration with the help of non-governmental and medical student organizations are recommended

Safety and efficacy of COVID-19 Vaccines in special populations

“…58,59 Vaccine efficacy in the general population, detailed efficacy and safety of Corona Vac can be retrieved in these publications. 59,60,61 Phase 3 trials were carried out in Brazil, 62 Turkey, 63 and Indonesia. The reported vaccination efficacy values (VE) in the general population ranged from about 51% in a Brazilian trial, 65% in Indonesian trial, and 84% in a Turkish trial.…”